Amlodipine Impurity 81 CAS CATO-C4X-109581
| CAS No. | CATO-C4X-109581 |
| Molecular Formula | C26H37ClN2O10 |
| Molecular Weight | 573.03 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Amlodipine Impurity 81.
Amlodipine Impurity 81 (CAS CATO-C4X-109581) is a certified pharmaceutical impurity reference standard with the molecular formula C26H37ClN2O10 and a molecular weight of 573.03 g/mol.
The molecular framework of Amlodipine Impurity 81 (C26H37ClN2O10) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C26H37ClN2O10 |
| Molecular Weight | 573.03 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Amlodipine Standards
- Amlodipine Impurity 104 (CAS CATO-C4X-1095104)
- Amlodipine Impurity 106 (CAS CATO-C4X-1095106)
- Amlodipine Impurity 107 (CAS CATO-C4X-1095107)
- Amlodipine Mannitol Adduct (CAS CATO-C4X-109571)
- Amlodipine N-Galactopyranoside (Mixture of Diastereomers) (CAS CATO-C4X-109511)
- Amlodipine Impurity 152 (CAS CATO-C4X-1095152)
- Amlodipine N-Glucose (CAS CATO-C4X-109546)
- Amlodipine Besylate EP Impurity B (CAS 721958-72-1)
Recommended Standards
- 9-[5-O-[Bis(4-methoxyphenyl)phenylmethyl]-2-deoxy-β-D-erythro-pentofuranosyl]-6-chloro-9H-purine (CAS 133931-96-1)
- 1-(2-(4-Bromo-2-chlorophenoxy)ethyl)-4-((tert-butyldiphenylsilyl)oxy)piperidine (CAS 1704080-89-6)
- N-{[(4-chlorophenyl)carbamoyl]amino}-4-[4-(diphenylmethyl)piperazine-1-carbonyl]-5-methyl-1,2-oxazole-3-carboxamide (CAS 338408-78-9)
- Neratinib Impurity 15 (CAS 1376615-55-2)
- Tadalafil Impurity 150 (CAS 2361527-35-5)
- Riboflavin Impurity 25 (CAS CATO-C4X-181925)
- Posaconazole Impurity 64 (CAS CATO-C4X-120864)
- Tetrabromobisphenol S Dimethyl Ether (CAS 70156-79-5)
- 7,7-dimethyl-1$l^{6},4-thiazepane-1,1-dione hydrochloride (CAS 1787855-34-8)
- (4-{2-[(4-chlorophenyl)sulfanyl]ethoxy}phenyl)methanamine hydrochloride (CAS 1258641-46-1)
- 6-Benzyl-6,7-dihydro-5H-pyrrolo[3,4-b]pyridine (CAS 109966-30-5)
- N1-(6-(Piperidin-1-yl)pyrimidin-4-yl)ethane-1,2-diamine (CAS 1706442-97-8)
- Methotrexate impurity 51 (CAS CATO-C4X-115451)
- Semaglutide impurity 33 (CAS CATO-C4X-222633)
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